2015 APEC Business Ethics for SMEs Forum Biopharmaceutical Sector Workshop

2015 APEC Business Ethics for SMEs ForumBiopharmaceutical Sector Workshop 19 August 2015│ Manila, Philippines

Ms. Lynn CostaProject Overseer, Business Ethics for APEC SMEs InitiativeSenior Policy Advisor for Global MarketsU.S. Department of CommerceThe United States

Participant Introductions &Status Updates by Associations

SESSION ONEAssociation Leadership in Strengthening Ethical Practices

Session One: Association Leadership in Strengthening Ethical Practices Moderator: Ms. Maria “Maru” Quindimil (The Philippines) Panelists: Ms. Deborah Monk, Medicines Australia (Australia) Ms. Chrisoula Nikiidis, Rx&D (Canada) Mr. Pan Guang Cheng, CPIA (China) Mr. DarodjatunSanusi, G.P. Farmasi (Indonesia) Ms. Claudia Perez, ANAFAM (Mexico)

Deborah MonkDirector, ComplianceMedicines Australia

The Industry is Responsible for its Reputation • Failure to adhere to high standards negatively affects the whole industry’s reputation, not just one company’s

Why adopt a Code of Ethics? • A platform for demonstrating that companies’ interactions with healthcare professionals and patients are legitimate, and therefore should be permitted • A strong self-regulatory Code, effectively communicated and enforced, is our licence to operate • There is Strength in Unity in adopting ethical business practices

Industry Associations are a hub for... • Establishinga Code • Reviewingand revising the Code on a regular basis • Providing training for members and other organisations (e.g. agencies, third party vendors) • Monitoringcompliance with the Code • Taking appropriate remedialaction where non-compliance is detected • Communicatingeffectively to external parties about the ethical business practices of the industry

APEC WorkshopSession 1Chrisoula NikidisRx&D Canada

Forces in the Universe Individual Company Code US Foreign Corrupt Practices Act UK Bribery Act Local Associations Codes Health Care Professional Associations Patient Group Codes Rx&D Code of Ethical Practices EFPIA Transparency Guidelines IFPMA Canadian Corruption of Foreign Public Officials Act APEC and Mexico City Principles

Consensus Framework for Ethical Collaboration • A consensus framework established for ethical collaboration between patients’ organisations, healthcare professionals and the pharmaceutical industry in support of high quality Patient care

推行医药企业伦理准则 营造健康医药产业环境Promoting EthicsPrinciples in biopharmaceutical industry, building healthy environment of biopharmaceutical industry 中国化学制药工业协会常务副会长潘广成 Standing vice president of China Pharmaceutical Industry Association 2015年8月19-20日菲律宾·马尼拉 19-20 August, 2015 Manila Philippine

很高兴受邀参加本届APEC 中小企业商业道德论坛并与国外制药业同行进行交流 I am honored to attend 2015 APEC Business Ethics Forum and learn from our colleagues 中国化学制药工业协会（CPIA）是1988年9月经中国民政部批准正式注册的全国4A级行业协会。目前有316家会员单位，其主营业务收入和利润占化学制药行业60%以上 CPIA was registered in September 1988 and approved as a 4-A industry association by the Ministry of Civil Affairs of China.CPIA now has 316 members whose major business volume and profit covering more than 60% of the pharmaceutical industry in China. 下面，向大家介绍中国化学制药工业协会（CPIA）在推进实施《医药企业伦理准则》方面所做的工作及后续规划 The following is the report on the achievements and future plan by CPIA in the promoting executing ethics principles for biopharmaceutical enterprises.

改革开放三十多年来，中国经济发展创造了世界奇迹，中国医药行业更是以高于全国工业的整体增速迅猛发展改革开放三十多年来，中国经济发展创造了世界奇迹，中国医药行业更是以高于全国工业的整体增速迅猛发展 With the opening reform in over 30 years, the Chinese economic has made the world known achievements, the Chinese pharmaceutical industry has made the development even bigger and faster than the general industry increase. 2014年，中国医药工业主营业务收入达到2.45万亿人民币（约合3950亿美元） In 2014, the major business revenue of the Chinese pharmaceutical industry reached 395 billion USD.

面对中国已成为世界第二大医药市场的现状，要在市场竞争中把握道德底线不动摇，必须坚持以诚为利，以信为赢面对中国已成为世界第二大医药市场的现状，要在市场竞争中把握道德底线不动摇，必须坚持以诚为利，以信为赢 China is now the second largest pharmaceutical market,it is very important to hold stablely the ethics line, and sticting to faith and credit 随着中国医疗卫生体制改革的不断深化，业界要求自觉践行行业自律，倡导企业诚信合规经营的呼声日益高涨，在中国推行《医药企业伦理准则》的时机已经成熟 As the reform of the Chinese medical and health system is deepening, the industry is called to follow up more closely the industry principles. It is the time that 《the ethics principles for biopharmaceutical enterprises》 is being promoted in China.

2011年9月，亚太经合组织（APEC）在墨西哥提出了生物制药领域的商业道德准则——《墨西哥城原则》，为中国推进实施《医药企业伦理准则》提供了经验2011年9月，亚太经合组织（APEC）在墨西哥提出了生物制药领域的商业道德准则——《墨西哥城原则》，为中国推进实施《医药企业伦理准则》提供了经验 In September 2011， APEC launched business ethics in Mexico (The Mexico City Principles) for biopharmaceutyical sector, which provides experiences for China to execute 《ethics principles for biopharmaceutical enterprises》在当前中国药品安全形势比较严峻的背景下，发起推行《医药企业伦理准则》对于规范企业经营、重拾消费者对行业的信心都有积极作用 At present, in China, promoting the 《ethics principles for biopharmaceutical enterprises》 is very important for regulating the business operation and set up the confidence of people for the industry

一、将《墨西哥城原则》引入中国 Introducing (The Mexico City Principles) into China 2012年7月，CPIA受邀派代表参加了APEC在台北召开的“关于生物制药业志愿实施企业伦理准则草案研讨会” In July, CPIA sent its representatives to attend in Taibei the "forum for biopharmaceutical enterprises to executing voluntarily the ethics principles" 2012年8月，CPIA受邀参加了APEC在吉隆坡举办的“生物制药行业、医疗器械行业、建筑工程行业商业道德自愿行动准则培训班” In August 2012, CPIA was invited to attend the training course organized in Kuala Lumpur for "biopharmaceutical sector, medical device sector and construction/engineering sector to practice voluntarily the business ethics

2013年8月，CPIA与中国医保商会、中国药促会商榷并达成共识，将《墨西哥城原则》引入中国，中国译本定名为《医药企业伦理准则》2013年8月，CPIA与中国医保商会、中国药促会商榷并达成共识，将《墨西哥城原则》引入中国，中国译本定名为《医药企业伦理准则》 In August 2013, CPIA, CCCMHPIE, PHIRDA discussed and agreed to introduce (The Mexico City Principles) into China, which it named as 《ethics principles of biopharmaceutical enterprises》in Chinese 2013年11月，在“中国化学制药行业年度峰会”上，有5家医药行业协会推出了《医药企业伦理准则》 In November 2013, in the "annual summit meeting of Chinese biopharmaceutical industry", 5 industry associations proposed《ethics principles of biopharmaceutical enterprises》

二、成功举行了三次专题会议Held successfully 3 special meetings 2013年10月29日，“中国医药企业伦理准则发布大会”在中国北京举行，9家中国医药协会当场签署了《医药企业伦理准则》倡议书 29 October 2013, the Launching meeting of ethics principles for Chinese biopharmaceutical enterprises was held in Beijing, 9 industry associations signed on site the initial written proposal of《ethics principles of biopharmaceutical enterprises》 2014年5月27日，在北京举办了“医药企业伦理准则中国论坛”，对《医药企业伦理准则》做更深层次的推动。在此推动下，中国医师协会颁布了《中国医师道德准则》，《医药企业伦理准则》在中国的推广取得了实质性进展 May 27, 2014, "China Forum of ethics principles of biopharmaceutical enterprises" was held in Beijing which further promote the execution of 《ethics principles of biopharmaceutical enterprises》.on the same period, the association of Chinese doctors launched 《ethics principles of Chinese doctors》.The promoted and execution of 《ethics principles of biopharmaceutical enterprises》in China have achieved practice progress.

2015年6月29日，9家医药协会在北京召开“2015医药企业伦理准则中国论坛”，主题为“多方联动 践行合规”，旨在加强医药卫生行业以及监管机构之间的协同。本次论坛新增8家医药行业相关协会签署了《医药企业伦理准则倡议书》，截至目前，中国已有17家医药相关行业协、会加入到了倡导《医药企业伦理准则》中来，具有广泛的代表性 29 June 2015, 9 pharmaceutical associations held in Beijing the "2015 China Forum of ethics principles of biopharmaceutical enterprises", the major topic was "multi action, practice ethics" with the purpose of enhancing the co-action of pharmaceutical and medical industry with the supervising authorities.This forum had added 8 new pharmaceutical related associations to sign on site the initial written proposal o《ethics principles of biopharmaceutical enterprises》.Up to now, in China, there are 17 pharmaceutical related associations joined the promotion of《ethics principles of biopharmaceutical enterprises》. June,

三、推行《医药企业伦理准则》规划安排Plan in promoting 《ethics principles of biopharmaceutical enterprises》

总体规划：加大宣传推广力度，开展合规政策、流程的培训，让更多的中小企业积极参与进来；加强与政府相关部门及利益相关方的互动沟通，及时向企业传达最新信息总体规划：加大宣传推广力度，开展合规政策、流程的培训，让更多的中小企业积极参与进来；加强与政府相关部门及利益相关方的互动沟通，及时向企业传达最新信息 General plan: increase propaganda and promotion, hold more trains on compliance policies and procedures, asking more MSEto join in; enhance the communication and exchange with the government authorities and stakers, and pass the newest information in time to the enterprises

（一）与利益相关方建立合作伙伴关系 Setting up collaboration partnership with stakers （二）利用各种渠道开展多种形式培训 Conducting various training based upon different channels （三）加强与政府各相关部门沟通协调 Increase communication and coordination with government authorities

（四）在行业内深入开展信用评价工作 Carry out credit evaluation work in the biopharmaceutical industry （五）在调研基础上积极开展宣传推广 Conduct proganda and promotion based on the research （六）在总结经验基础上完善准则内容 Optimize the content of the principles based upon the summarization of experiences

我们坚信，只要我们持续不断地将《医药企业伦理准则》推行下去，在国家政策的支持下，在各行业协会、各企业、各利益相关方的参与和共同努力下，这项工作一定会取得令人瞩目的成果，一定能为中国的医药行业创造一个健康、有序的市场环境。我们坚信，只要我们持续不断地将《医药企业伦理准则》推行下去，在国家政策的支持下，在各行业协会、各企业、各利益相关方的参与和共同努力下，这项工作一定会取得令人瞩目的成果，一定能为中国的医药行业创造一个健康、有序的市场环境。 We believe that based upon our insistence on promoting 《ethics principles of biopharmaceutical enterprises》,supported by the policy of the country, with the participation and efforts of all industry associations, enterprises and stakers,this work will surely obtain outstanding achievements, and create a health and order market environment for the pharmaceutical industry in China.

Leadership in Strengthening Ethical Practices (96 Mexican & Multinational Companies) (27 Mexican Companies) Council of Ethics of the Pharma Industry Ethics Code

Benefits for Being Affiliated • Adoption of theCode of Ethics of thePharmaIndustryissuedby CETIFARMA • Revise and up date of theCodeevery 3 years • ProvidesmonitoringcompliancewiththeCode • Providesadvisoryor training abouttheCodeifrequestedbycompanies • Grants a CertificationonTransparentPractices (EPT) to affiliates (a process of appraisalisrequiered) • Takesappropriateactionwhen non-complianceisdetectedorreportedbyanaffiliated • Fostersapproaching to healthauthorities, healthcareprofessionals, hospitals • Is a communication link betweentheIndustry and differenthealthAuthorities • Establishesgoodrelationshipswithinternationalself-regulationorganizationslike IFPMA to getknowledge and promoteethicalbusinesspractices of theindustry in othercountries

SESSION TWOBest Practices for Low Cost Implementaton of Codes of Ethics

Session Two: Best Practices for Low Cost Implementation of Codes of Ethics • Scene-Setting Remarks: • SME Perspective: Mr. Butch Sales (The Philippines) • Association Perspective: Sabrina Chan (Hong Kong) • Exercise Facilitator: • Ms. Karen Eryou, UCB (China)

The Role of the Industry Association on Code of Practice Sabrina Chan Executive Director The Hong Kong Association of the Pharmaceutical Industry August 2015

Myths of implementing Code of Practice • Is implementing the Code costly? • Is implementing a Code time consuming? • Is promoting a Code need a lot of additional human resources? • Will I lose the market • if my company does something different from other companies (which do not comply with the Code Of Practice); or • if my company does something different from the previous practice by which I will lose my existing customers

Some Business Questions Business opportunities vs. risk management considerations? • How to run a company in compliance with local law? • How to run a company to meet the expectation of customers/society? • How to run a company in compliance of company practice and rules - a proper corporate governance in the company? • How to run a company in accordance to the standard of the local industry? • Can you distinguish your market from the others by providing benefits?

The role of the Association - Develop a Code and Revisit the Code periodically

Key references for building /revising a code • The Hong Kong Code incorporates the principles set out in: • The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Pharmaceutical Marketing Practice • The World Health Organization’s Ethical Criteria for Medicinal Drug Promotion • The Mexico-City Principles • Leveraging professional knowledge • Learning from members • Learning from Associate members • Learning from law enforcement party ( e.g. Independent Commission Against Corruption) • Learning from Case Law • Learning from stakeholders ( Public Hospitals, Physicians, Pharmacists, Patients, Consumer Council)

The Code revision – the process of alignment

Promotion of Code internally • Training workshops • Cert med. rep. course • Train-the-trainer workshop • At least identified a ‘responsible person’ to join • Cases studies • A survey to develop some KPIs to check the progress of development and identifying the areas of future training • A workshop to be held in another half of the year.

KPIs to measure success Stage 1: Align internal SOP with CoP through member survey Quantitative: • No. of questions received from compliance officers • Any dedicated officer in the company • Frequency of training conducted in the past year • Any internal SOP set up • Are those SOPs aligned with CoP Qualitative: • Type of questions raised • Process to track internal compliance • Which part of CoP need improvements Stage 2 : Ethical thinking in every decision making • Workshop with cases help members understanding each participating companies’ and knowledge gap.

Promotion of Code – leverage the relationship with stakeholders

Myths of implementing Code of Practice • Is implementing the Code costly? • Is implementing a Code time consuming? • Is promoting a Code need a lot of additional human resources? • Will I lose the market • if my company does something different from other companies (which do not comply with the Code Of Practice); or • if my company does something different from the previous practice by which I will lose my existing customers

APEC Biopharmaceutical Workshop Structure for Session 2

APEC Biopharmaceutical Workshop Structure for Session 2 Pre-Survey to Workshop Day * Suggested Topics - see word doc

Table Topics & Mentors

LUNCH BREAK(Luzon Room – Next Door)11:30 – 13:00

CODE IMPLEMENTATION WORKSHOP

2015 APEC Business Ethics for SMEs Forum Biopharmaceutical Sector Workshop